Methods and implants for treating urinary incontinence

ABSTRACT

Described are methods, implants, insertion tools, and related systems and kits, for placing an implant to treat urinary incontinence; the implants include soft tissue anchors that are capable of engaging needles of the insertion tools, and the implants are designed to place a central support portion at a location to support a urethra with extension portions and soft tissue anchors extending to tissue at regions of an obturator foramen.

PRIORITY

This application is a divisional of U.S. patent application Ser. No.12/533,515, filed Jul. 31, 2009, which claims benefit from United StatesProvisional Patent Application having Ser. No. 61/085,247, filed on Jul.31, 2008, by Knoll, and titled INSTRUMENT AND METHOD FOR PLACEMENT OFMALE INCONTINENCE REPAIR SLING, the entire contents of which are allincorporated herein by reference in their entireties.

FIELD OF THE INVENTION

The invention relates to treating incontinence in a male patient using asurgical sling secured internally to support a urethra, includingmethods, implants (e.g., slings), insertion tools, and related systems.

BACKGROUND

For patients with urinary incontinence, lives are perpetuallyinterrupted by thoughts of ensuring that they have ready access to arestroom. Everyday activities such as attending a theater or sportingevent can become unpleasant. Sufferers often begin to avoid socialsituations in an effort to reduce the stress associated with theircondition.

A variety of treatment options are currently available for urinaryincontinence. One type of surgical procedure found to be an especiallysuccessful treatment option for incontinence in both men and women, is asling procedure. Sling procedures typically entail surgically implantinga biocompatible implant or “sling” to support the bladder neck orurethra. Sling procedures are discussed in U.S. Pat. Nos. 5,112,344;5,611,515; 5,842,478; 5,860,425; 5,899,909; 6,039,686; 6,042,534;6,110,101; 6,478,727; 6,638,211; and PCT Publication Nos. WO 02/39890and WO 02/069781.

An implant for placement in a male patient may require greater strength,different (e.g., larger) dimensions, and better retention ability intissue, relative to implants useful on a female patient. Also, methodsof placement of such an implant can involve different tissue paths,incisions, and placement of implant features at alternate anatomy.

U.S. patent publication 2006/0287571 (U.S. Ser. No. 11/347,047)describes procedures to implant a urethral sling in a male anatomy.Described methods involve placement of a sling below a bulbous urethra,for example in contact with a corpus spongiosum. Steps of exemplifiedmethods include creating a medial (e.g., perineal) incision, dissectingbulbospongiosus muscle to expose corpus spongiosum, and placing acentral support portion of a sling in contact with the corpusspongiosum. Extension portions of the sling are extended through tissuepaths to locations at which the extension portions can be secured to thepatient, to thereby support the sling in place.

U.S. patent application Ser. No. 12/223,846, filed Aug. 8, 2008, byOgdahl et al., titled SURGICAL ARTICLES AND METHODS FOR TREATING PELVICCONDITIONS describes, inter alia, methods and devices for treatingurinary incontinence in male patients. The methods involve a sling thatincludes two “soft tissue anchors” at opposite ends of a mesh strip. Thesling is placed internally in a male patient through a medial incision,the sling supporting the urethra and the soft tissue anchors beingplaced internally, e.g., at opposing obturator foramen.

As with other established medical treatments, there is ongoing incentiveand benefit in finding still improved treatments for urinaryincontinence. Improvements may be in the form of new method steps,improved implants, improved insertion tools, and related systems andprocedures.

SUMMARY

Methods as described are useful to treat urinary incontinence in a maleby placing an implant to support the urethra. The implant includes acentral support portion, extension portions extending from the centralsupport portion, and soft tissue anchors. According to the method, thesoft tissue anchors are placed at locations of soft tissue in a regionof an obturator foramen. Placing a soft tissue anchor and a distal endof an extension portion at a region of an obturator foramen, preferablyat tissue of endopelvic fascia, short of muscle tissue of the obturatorforamen, i.e., on the bladder side of the obturator foramen, can allowplacement of soft tissue anchors at locations away from nerves and bloodvessels of the obturator foramen, and also away from the bladder.

Embodiments of the invention also relate at least in part to methods oftreating urinary incontinence in a male patient by placing a sling(implant) to support a urethra, wherein the sling includes at least foursoft tissue anchors located at ends of extension portions, two softtissue anchors at distal ends of extension portions on opposing (e.g.,left and right) sides of an implant.

Insertion tools can be used according to the methods, with implants asdescribed. The insertion tools include a handle and elongate structure(e.g., one or multiple needles) extending from the handle to a locationdistal from the handle, that can engage one or two soft tissue anchors.E.g., the insertion tool can include two distal tip structures capableof engaging two soft tissue anchors on one side of an implantsimultaneous, to allow handling and manipulation of the two soft tissueanchors and allow a user to place the two soft tissue anchors at softtissue, together, in one step.

In one aspect the invention relates to an implant for treating urinaryincontinence in a male. The implant includes: a central support portioncomprising two opposing sides and two opposing ends, and capable ofsupporting a urethra; at least two extension portions extending fromopposing sides of the central support portion, each extension portioncomprising a proximal end attached to the central support portion, and adistal end; and four soft tissue anchors, each located at a distal endof an extension portion. When the central support portion is placed tosupport the urethra, the extension portions are capable of extendingfrom the central support portion to soft tissue at a region of anobturator foramen.

In another aspect the invention relates to an insertion tool useful toplace a sling for urinary incontinence. The insertion tool includes: ahandle; a first needle comprising a proximal end and a distal end, theproximal end connected to the handle and the distal end adapted toengage a soft tissue anchor; and a second needle comprising a proximalend and a distal end, the proximal end connected to the handle and thedistal end adapted to engage a soft tissue anchor.

In another aspect the invention relates to a method of treating urinaryincontinence in a male. The method includes providing an implantcomprising: a central support portion comprising two opposing sides andtwo opposing ends, and capable of supporting a urethra; at least twoextension portions extending from opposing sides of the central supportportion, each extension portion comprising a proximal end attached toth_(e) central support portion, and a distal end; and four soft tissueanchors, each located at a distal end of an extension portion, two on aright side of the implant and two on a left side of the implant. Whenthe central support portion is placed to support the urethra, theextension portions are capable of extending from the central supportportion to soft tissue at a region of an obturator foramen. The methodfurther includes providing an insertion tool comprising: a first needlecomprising a proximal end and a distal end, the proximal end connectedto the handle and the distal end adapted to engage a soft tissue anchor;and a second needle comprising a proximal end and a distal end, theproximal end connected to the handle and the distal end adapted toengage a soft tissue anchor. The method further includes creating amedial incision at a perineum, placing the central support portion tosupport a urethra, engaging the two needle tips with two soft tissueanchors on a right side of the implant and placing the soft tissueanchors through tissue paths extending toward a region of an obturatorforamen on one side of the patient, and engaging the two needle tipswith two soft tissue anchors on a left side of the implant and placingthe soft tissue anchors through tissue paths extending toward a regionof an obturator foramen on another side of the patient.

The entireties of the content of all patent documents cited herein areincorporated herein by reference.

BRIEF SUMMARY OF THE FIGURES

FIG. 1 shows an embodiment of an implant as described.

FIG. 2 shows an embodiment of an implant as described.

FIGS. 3A, 3B, and 3C shows an embodiment of an insertion tool asdescribed.

DETAILED DESCRIPTION

The following description is meant to be illustrative only and notlimiting. Other embodiments of this invention will be apparent to thoseof ordinary skill in the art in view of this description.

The present invention is directed to surgical instruments, assemblies,and implantable articles for treating urinary incontinence in a malepatient, e.g., stress urinary incontinence (SUI). Described are variousfeatures of surgical implants, surgical tools, surgical systems,surgical kits, and surgical methods, useful for installing implants.Useful implants can include a tissue support portion (or “centralsupport portion”) that can be used to support a urethra. Useful implantsalso include one or more extension portions (otherwise known as “end”portions or “arms”) attached to the tissue support portion. Soft tissueanchors are attached at distal ends of extension portions, including atleast two soft tissue anchors at distal ends of one or more extensionportion on a first (“right”) side of an implant and at least two softtissue anchors at distal ends of one or more extension portion on asecond (“left”) side of an implant.

Methods as described are useful to treat incontinence in a male byplacing an implant below a urethra, to support (i.e., support orapproximate) the urethra. Soft tissue anchors are used to secure theimplant at a desired supportive location, by securing the soft tissueanchors to internal soft tissue at regions of an obturator foramen.According to exemplary techniques, a physician (e.g., surgeon) is ableplace an implant at a location to support a male urethra, betweenlocations at opposite obturator foramen, the implant being anchoredinternally by soft tissue anchors, the soft tissue anchors being placedat opposing regions of opposing obturator foramen. When the implant isplaced, two soft tissue anchors, each located at a distal end of anextension portion, extend from the central support portion (below theurethra) to a region of an obturator foramen on one side of a patient,and two soft tissue anchors, each located at a distal end of anextension portion, extend to a region of an obturator foramen on anopposite side of a patient.

As used herein, tissue at a “region of an obturator foramen” refers tosoft tissue within or proximal to an obturator foramen or surroundingpubic bone, specifically including endopelvic fascia, musculature(including musculature of the obturator foramen), and nearby ligaments,tendons, and muscle tissues. “Endopelvic fascia” refers to soft tissuebetween a bladder and a pelvic bone (i.e., musculature of the pelvicbone), including soft tissue that covers muscle attached to the pelvicfloor and the obturator foramen, on the bladder side of the pelvic bone.Accordingly, endopelvic fascia includes tissue that is reached bycreating a tissue path beginning at a location below a male urethra(e.g., below a bulbous urethra, optionally beginning at a corpusspongiosum or a bulbospongiosus muscle at a location below a bulbousurethra) and extending toward an obturator foramen to a location nearbut not in contact with (short of) the obturator internus muscle ornearby muscle tissues, as well as tissue that is proximate to such atissue path.

An exemplary method of installing a male urethral sling can include astep of creating a perineal (e.g., medial) incision at the external maleperineum; creating opposing tissue paths from the medial incision, belowthe urethra, to regions of the patient's left and right obturatorforamen; and installing a urethral sling that includes extensionportions with soft tissue anchors at distal ends, at regions of theopposing left and right obturator foramen. The implant includes at leasttwo soft tissue anchors at distal ends of extension portions on eachside of the implant, and the method includes placing at least two softtissue anchors at a region of an obturator foramen on one side of thepatient, and placing at least two soft tissue anchors at a region of anobturator foramen on a second (opposite) side of the patient.

Preferred methods of the invention can treat urinary incontinence in amale by supporting (meaning to support, position, re-position, orapproximate) tissue of a urethra or a urethral sphincter complex, in anyway that improves coaptation of the urethra, resulting in improvedcontinence. According to one embodiment, a central support portion of asling may be placed below the bulbospongiosus muscle and tensioned toreposition pelvic tissue and improve continence.

In preferred embodiments, a urethral sling can be installed in a malepatient with the central support portion of the sling in direct contactwith the corpus spongiosum. See U.S. Publication No. 2006-0287571. Forexample, a method can include providing a medial incision at theperineum of a male patient to a expose bulbospongiosus muscle,optionally and preferably dissecting through bulbospongiosus muscle toexpose s corpus spongiosum, and placing a central support portion of aurethral sling in contact with the corpus spongiosum. Optionally thecentral support portion can be fixed to the corpus spongiosum, such asby use of a medical attachment in the form of a suture, staple,adhesive, or the like.

An insertion tool can engage soft tissue anchors on the implant, twosoft tissue anchors on a right side of the implant and two soft tissueanchors on a left side of the implant. The insertion tool can be used tocreate a tissue path extending to a region of an obturator foramen, orto place the soft tissue anchors within a previously-prepared tissuepath. The sling can be tensioned to approximate tissue at or around theurethra, to improve continence, and tension can optionally andpreferably be maintained chronically.

In the exemplary embodiment, approximation of the corpus spongiosum cancause movement or relative movement of or between the urethra and therhabdosphincter to allow the rhabdosphincter to better coapt the urethraand achieve improved or complete continence. Again not wishing to bebound by theory, approximating the corpus spongiosum may have thetherapeutic effect of lifting and rotating tissue of the urethra, rhabdosphincter, or both, into a more physiologically normal position. Asshown in FIG. 3, the urethra can be moved in a direction parallel to thelength-wise direction of the urethra. Upon tissue ingrowth into thesling, the rhabdosphincter will have a more rigid backboard by which tooperate against when collapsing the urethra. Improved positioning of therhabdosphincter can be especially useful for men who have had the dorsalrhabdosphincter ruptured due to radical prostatectomy, and the musclecan no longer work against itself to collapse the urethra but ratherneeds to work against another rigid structure to be efficient.

The soft tissue anchors Preferably, the soft tissue anchors includelateral extensions (e.g., two, of the same size and shape and form,extending in opposite directions from opposite sides of the base). Theurethral sling may be placed using one or more insertion tools asdescribed, by installing extension portions of the sling between themedial incision and regions of obturator foramen, with the centralsupport portion of the sling positioned below the urethra. The extensionportions may be pushed through the tissue path at the lead of aninsertion tool that engages soft tissue anchors and pushes the softtissue anchors through tissue. The tissue support portion (centralportion) of the urethral sling may be placed as desired, below the maleurethra, to support the urethra, optionally with approximation,compression, or a combination of approximation and compression.Adjustment of the implant can be performed based on the location (pointof entry) and depth of insertion of soft tissue anchors within softtissue of the opposing regions of obturator foramen. The central supportportion may be placed below the bulbospongiosus muscle or below thecorpus spongiosum, as desired. The sling may optionally include awidened central support portion that is placed to contact the corpusspongiosum, and the support portion and sling are used to approximatethe urethra to improve continence, e.g., without the need forcompression of the urethra. See, e.g., U.S. Publ. No. 2006/0287571 andU.S. Pat. No. 7,422,557.

Implant useful according to described methods can include a centralsupport portion, extension portions extending from the central supportportion, and soft tissue anchors at distal ends of the extensionportions. In particular, implants can include at least four soft tissueanchors, each located at an end of an extension portions, e.g., two softtissue anchors, each located at an end of one or more extension portionon, a right side of an implant; and two soft tissue anchors, eachlocated at an end of one or more extension portion, on a left side of animplant.

The implant may include portions or sections that are synthetic or ofbiological material (e.g., porcine, cadaveric, etc.). Extension portionsmay be, e.g., a synthetic mesh such as a polypropylene mesh. The centralsupport portion may be synthetic (e.g., a polypropylene mesh) orbiologic. Examples of implant products that may be similar to thoseuseful according to the present description, include those soldcommercially by American Medical Systems, Inc., of Minnetonka Minn.,under the trade names Apogee® and Perigee® for use in treating pelvicprolapse (including vaginal vault prolapse, cystocele, enterocele,etc.), and Sparc®, Bioarc®, and Monarc® for treating urinaryincontinence.

Exemplary implants can include a tissue support portion for placing incontact with tissue to be supported and one or more “extension”portions, the tissue support portion being useful to support a specifictype of pelvic tissue such as the urethra, bladder, or vaginal tissue(anterior, posterior, apical, etc.). The tissue support portion can besized and shaped to contact the desired tissue when installed, e.g., asa “sling” or “hammock,” to contact and support pelvic tissue. A tissuesupport portion that is located between two or more extension orextension portions is sometimes referred to herein as a “central supportportion” or a “support portion.”

A central support portion is located between two (or more, e.g., four)opposing elongate extension portions. The central support portion may beintegral with the extension portions as the same material, having thesame (total) width and thickness, or may be of another material havingdifferent width and thickness dimensions. The central support portion isattachable to or integral with the extension portions and can becomposed of a porous or non-porous plastic materials, a biologicmaterial, or the like, such as a thermoplastic (e.g., polypropylene).

Extension portions are elongate pieces of material having a proximal endattached to the central support portion, and that extend away from thecentral support portion to a distal end. One or more soft tissue anchorscan be connected to the distal end. The extension portion and softtissue anchor (or anchors) can reach and be connected to a region of anobturator foramen to provide support for the central support portion.Two or more (e.g., four) extension portions can extend from the centralsupport portion.

Examples of useful implants include supportive portions that include orconsist of: a central support portion; either two or four elongateextension portions extending from the central support portion; and foursoft tissue anchors, each soft tissue anchor at an end of an extensionportion. The term “supportive portions” refers to portions of an implantthat function to support tissue after the implant has been implanted,and specifically includes extension portions, central support portions,and soft tissue anchors, and does not include optional or appurtenantfeatures of an implant such as a sheath, or a tensioning suture or othertensioning device. Examples of these implants include a central supportportion and two extension portions, each extending from an opposite sideof the central support portion and each having two soft tissue anchorslocated (side-by-side) at the ends of the extension portions. Otherexamples include a central support portion and four extension portions,two extension portions extending from each of opposite sides of thecentral support portion, and each of the four extension portions havinga soft tissue anchor located at the distal end of the extension portion.With such implants, other optional feature may also be included, such asone or more tensioning sutures.

An implant may be integral, monolithic, or a composite of differentcomponents or segments of different synthetic or non-synthetic (e.g.,“biologic”) components. Suitable non-synthetic materials includeallografts, homografts, heterografts, autologous tissues, cadavericfascia, autodermal grafts, dermal collagen grafts, autofascialheterografts, whole skin grafts, porcine dermal collagen, lyophilizedaortic homografts, preserved dural homografts, bovine pericardium andfascia lata. Suitable synthetic materials for a sling includepolymerics, metals, and plastics and any combination of such materials.

Examples of synthetic sling materials include polypropylene, cellulose,polyvinyl, silicone, polytetrafluoroethylene, polygalactin, Silastic,carbon-fiber, polyethylene, nylon, polyester (e.g. dacron) PLLA and PGA.The sling material may be resorbable, absorbable, or non-absorbable.Optionally, some portions may be absorbable and other portions may benon-absorbable. Commercial examples of synthetic materials useful in aurethral sling include Marlex™ (polypropylene) available from Bard ofCovington, R.I., Prolene™ (polypropylene) and Mersilene (polyethyleneterephthalate) Hernia Mesh available from Ethicon, of New Jersey,Gore-Tex™ (expanded polytetrafluoroethylene) available from W. L. Goreand associates, Phoenix, Ariz., and the polypropylene sling available inthe SPARC™ sling system, available from American Medical Systems, Inc.of Minnetonka, Minn. Commercial examples of absorbable materials includeDexon™ (polyglycolic acid) available from Davis and Geck of Danbury,Conn., and Vicryl™ available from Ethicon. Other examples of suitablematerials include those disclosed in U.S. Pat. Publ. No. 2002/0072694.

Dimensions of an extension portion according to the invention can allowan extension portion to reach between a central support portion placedto support pelvic tissue (at an end of the extension portion connectedto the tissue support portion) and a location at which the distal end ofthe extension portion attaches to pelvic tissue. A distal end of anextension portion, can include one or more soft tissue anchor tip thatcan be attached to tissue at a region of an obturator foramen, such asmuscle, ligament, fascia, or other soft tissue. The length of theextension portion, therefore, can be in a range that allows placement ofa tissue support portion as desired to support a urethra, while the softtissue anchors are installed in tissue of a region of an obturatorforamen.

The length of an implant (“length” refers to a dimension generallybetween opposing extension portions, including lengths of two opposingextension portions and a central support portion) between distal ends ofextension portions, can be sufficient to place the central supportportion below a urethra, to support the urethra, and to place opposingsoft tissue anchors at opposing regions of a patient's obturatorforamen. Exemplary lengths of an implant (L1 at FIG. 1) includinglengths of two opposing extension portions and a central support portion(dimensions are measured while an implant lies flat), can be in therange from about 2 to 3 inches. Exemplary lengths of an extensionportion (L2 at FIG. 1) can be in the range from about 0.8 to 1.2 inches(including a length of a soft tissue anchor). Exemplary lengths of acentral support portion (L3 at FIG. 1) can be in the range from about0.5 to 0.7 inches.

Placing a distal end of an extension portion at endopelvic fascia, shortof muscle tissue of the obturator foramen, i.e., on the bladder side ofthe obturator foramen, can allow placement of soft tissue anchors atlocations away from nerves and blood vessels of the obturator foramen,and also away from the bladder. Placing a distal end of an extensionportion at endopelvic fascia, short of muscle tissue of the obturatorforamen also allows for an extension portion of an implant to beslightly shorter than extension portions designed to anchor at obturatorforamen musculature (e.g., obturator internus muscle or obturatorexternus muscle), or extension portions designed to pass through theobturator foramen (e.g., to an external incision).

Not illustrated at FIGS. 1 and 2, but optionally a feature of animplant, opposing “bottom” (or posterior) extension portions canoptionally be slightly shorter than the “top” (anterior) extensionportions; when an implant is placed to support a urethra, a distancebetween a posterior location of the central support portion to a regionof an obturator foramen may be less than a distance from an anteriorlocation of the central support to a region of an obturator foramen. Forexample, a posterior extension portion may be from 0.2 to 0.4 inchshorter than an anterior extension portion.

Exemplary widths of an extension portion can be as desired, and may bebased on factors including the number of extension portions extendedfrom one side of a central support portion of an implant. FIG. 1 showsan implant having a total of two extension portions, one on each side ofa central support portion, each extension portion having two soft tissueanchors at a distal end. A width (W1 at FIG. 1) of such extensionportion, accommodating the presence of two soft tissue anchors, can bein the range from about 0.5 to 0.7 inches. Alternately, a width of anextension portion that accommodates only a single soft tissue anchors(see W2 at FIG. 2) can be approximately half of that width, such as fromabout 0.2 to 0.4 inches.

A preferred sling for placement against a corpus spongiosum may alsoinclude a central support portion that is wider than the one or moreextension portions of an implant. A widened central support portion canprovide improved mechanical and frictional engagement between thecentral support portion and the corpus spongiosum. A widened centralsupport portion provides a larger area of contact between the sling andcorpus spongiosum, and can have a reduced tendency to fold or deformupon tensioning of the sling. A suture can be used to attach the centralsupport portion to the corpus spongiosum to further improve the area ofcontact and prevent folding, such as at a location on the anterior sideof the central support portion. A suture may also be useful to preventmovement of the sling relative to the corpus spongiosum during or afterinstallation or tensioning.

Exemplary widths of a central support portion can be as desired tosupport a male urethra as described herein, and may vary based onfactors such as whether extended portions are desired, extending(forward and backward) beyond the total widths of the one or moreextension portions on each side of a central support portion. FIG. 1shows a central support portion that includes optional portions (lobes)extending forward and backward beyond the width of extension portions.The distance D1, which is the width of a lobe, can be as desired, e.g.,from 0.3 to 0.5 inches. The width W1 of the median portion (the centralsupport portion exclusive of lobes 103 and 104) of the ;central supportportion matches the width W1 of the extension portions, and may be fromabout 0.5 to 0.7 inches. The distance D2, which is the width of theopposite lobe, can be as desired, e.g., from 0.3 to 0.5 inches.

An implant as described can include one or multiple soft tissue anchorslocated at distal ends of each extension portion. A soft tissue anchorcan in general be a structure connected to a distal end of an extensionportion, that can be implanted into soft tissue in a manner that willmaintain the position of the soft tissue anchor and the attachedimplant. Preferred soft tissue anchors can also be designed to engage anend of an insertion tool (e.g., elongate needle, elongate tube, etc.) sothe insertion tool can be used to push the soft tissue anchor throughtissue or a pre-formed tissue path, for implantation. The soft tissueanchor may engage the insertion tool at an internal channel of the softtissue anchor, at an external location such as at the base, or at alateral extension, as desired. Examples of soft tissue anchors aredescribed, e.g., in U.S. Ser. No. 12/223,846, filed Aug. 8, 2008, byOgdahl et al., titled SURGICAL ARTICLES AND METHODS FOR TREATING PELVICCONDITIONS.

A soft tissue anchor can be made of any useful material, generallyincluding materials that can be molded or formed to a desired structureand connected to or attached to an end of an extension portion of animplant. Useful materials can include plastics such as polyethylene,polypropylene, and other thermoplastic or thermoformabl_(e) materials,as well as metals, ceramics, and other types of biocompatible andoptionally bioabsorbable or bioresorbable materials. Exemplarybioabsorbable materials include, e.g., polyglycolic acid (PGA),polylactide (PLA), copolymers of PGA and PLA.

A soft tissue anchor can be located at a distal end of an extensionportion, or alon_(g) a length of an extension portion. Either type canhave any general shape or design to allow an extension portion to beplaced in and secured to soft tissue. Examples of useful soft tissueanchors can include one or more lateral extensions (e.g., teeth, barbs,hooks, tines, etc.) that can increase the force required to remove thesoft tissue anchor from tissue after insertion into the tissue, i.e. the“pullout force.” At the same time, an extension portion can be designedto exhibit a reduced or relatively low “insertion force,” which is theamount of force used to insert the soft tissue anchor into tissue.

According to exemplary embodiments, a soft tissue anchor designed toattach to a distal end of an extension portion can have structure thatincludes a base having a proximal base end and a distal base end. Theproximal base end can be connected (e.g., directly or indirectly) to adistal end of an extension portion. The base extends from the proximalbase end to the distal base end and can optionally include an internalchannel extending from the proximal base end at least partially along alength of the base toward the distal base end. An optional internalchannel can be designed to interact with (i.e., engage) a distal end ofan insertion tool to allow the insertion tool to be used to place thesoft tissue anchor at a location within pelvic tissue of the patient.

Optionally, additional soft tissue anchors can be located at anextension portion, along a length of the extension portion at a locationbetween a proximal end of an extension portion (attached to a centralsupport portion) and a distal end of a support portion. These softtissue anchors can extend from a surface or edge of an extension portionand can provide added support of the central support portion byincreasing resistance to movement of the extension portion away fromtissue of a region of obturator foramen. These soft tissue anchors maybe in the form of a barb, hook, tooth, wedge, arrow, or otherwise-shapedstructural feature that contacts soft tissue (fascia, e.g., endopelvicfascia) between a urethra and a location of a distal end of an installedextension portion, i.e., a location at a region of an obturator foramen.These soft tissue anchors can be made of materials as described herein,and can be constructed to adhere _(to) or otherwise be attached to asurface or edge of an extension portion, with one or more extensionportion being structured to contact and frictionally engage tissue.

Referring to FIG. 1, an exemplary embodiment of an implant is shown.Implant 100 includes central support portion 102, which includes a midportion and two lobes, 103 and 104 (e.g., anterior and posterior lobes,collectively considered to be the central support portion). Twoextension portions 106 extend from opposite sides (in dashed lines) ofcentral support portion 102, from proximal ends connected to centralsupport portion 102 to distal ends. At distal ends of each extensionportion 106 are soft tissue anchors 112, which engage with implantationtools (not shown) and which can be placed in soft tissue. While notspecifically illustrated, an implant as illustrated may include otherappurtenant features such as edge extension reinforcement as describedabove (e.g., a reinforcing coating, reinforcing weave, reinforcingstrand, heat treatment, etc.).

Referring to FIG. 2, implant 100 includes features similar to those ofFIG. 1 and additionally includes two extensions portions 106 extendingfrom each side of central support portion 102 (as opposed to the twoextension portions illustrated at FIG. 1). The illustrated face ofimplant 100 of FIG. 2 also includes four additional soft tissue anchors110 located on the illustrated side surfaces of extension portions 106along lengths of extension portions 106 between proximal ends and distalends. One such soft tissue anchor 110 is shown per extension portion106, although more than one per extension portion can alternately beused. Also, the illustrated soft tissue anchors 110 are in the form ofthree-dimensional wedge-shaped soft tissue anchors having pointed distalend 114 and blunt proximal end 116. Other shapes that would allow forinsertion of the extension portions in a (distal) direction toward aregion of an obturator foramen (see arrow A) and result in resistance tomotion in a opposite (proximal) direction (arrow B), will also beuseful. As shown at FIG. 2, tissue anchors 110 are located on theillustrated side surfaces of implant 100; the other (non-illustrated)sides of each extension portion 106 can also, optionally, include one ormore soft tissue anchors 110.

One or more insertion tool can be used to install an implant asdescribed, by methods described. Various types of insertion tools areknown that will be understood to be useful for placing an implant asdescribed, having soft tissue anchors, to treat incontinence. Thesetypes of tools and modifications thereof can be used according to thisdescription to install an implant. Examples of useful tools includethose types of tools that generally include a thin elongate needle(optionally multiple needles, as described herein) attached to a handle;a handle attached to one end (a proximal end) of the needle; and adistal end of the needle adapted to engage a soft tissue anchor thatallows the needle to push one or more soft tissue anchor through atissue passage and insert the soft tissue anchor within tissue of thepelvic region. This class of tool can be used with a soft tissue anchorthat includes an internal channel designed to engage a distal end of aninsertion tool. Other general types of insertion tools will also beuseful but may engage a soft tissue anchor in a manner that does notinvolve an internal channel of a soft tissue anchor. These alternateinsertion tools may for example contact or grasp a proximal base end ofa soft tissue anchor in the absence of an internal channel extendingfrom the proximal base end toward the distal base end, such as bygrasping an external surface of the base. An alternate insertion toolmay contact or grasp a side of the base, a lateral extension, or anyother portion of the soft tissue anchor or base, in a way that allowsthe insertion tool to hold the soft tissue anchor and insert the softtissue anchor at a desired location within tissue of the pelvic region.

Exemplary insertion tools for treatment of incontinence and vaginalprolapse are described, e.g., in U.S. patent application Ser. Nos.10/834,943, 10/306,179; 11/347,553; 11/398,368; 10/840,646; PCTapplication number 2006/028828; and PCT application number 2006/0260618;among others. Tools described in those patent documents are designed forplacement of an implant in a pelvic region for the treatment ofprolapse, male or female incontinence, etc. The tools of theabove-referenced patent documents may be curved in two or threedimensions, and may include, for example, a two-dimensionally curvedneedle for placing an extension portion of an implant through a tissuepath that passes from a region of the urethra to a region of anobturator foramen.

In certain embodiments, a tool can include a handle or a portion of ahandle that exhibits a non-circular form when viewed along thelongitudinal axis of the handle. The non-circular cross-section can be,e.g., an oval, rectangle, rhombus, etc., having one dimension “width”that is greater than the dimension perpendicular to that “width.” Thenon-circular form will provide surfaces on the handle for a surgeon toplace pressure onto and to achieve a grip. The non-circularcross-sectional form can also preferably define a midplane that is aplane that includes the longitudinal axis of the handle and extendsalong the widest dimension of the handle when viewed in cross section.

Exemplary insertion tools can be similar to or can include features oftools described in the above-referenced patent documents. For useaccording to methods described herein, those insertion tools may bemodified to allow the insertion tool to be used to accommodate implantsas described, having two soft tissue anchors at ends of one or moreextension portions, e.g., as illustrated at FIGS. 1 and 2. For example,an insertion tool can include two tips (or “engaging surfaces,” e.g.,distal ends of needles) or other structures that engage two soft tissueanchors simultaneously and (optionally) in a side-by-side configuration.The tips may conveniently be located at distal ends of two separateneedles that extend side-by-side from a single handle. The tool can bedesigned to place two soft tissue anchors, side-by-side, at soft tissueat a region of an obturator foramen, e.g., two side-by-side needles canbe sized and shaped to be inserted simultaneously through a medialincision (e.g., perineal incision in a male) and to extend from thatincision to a location of an obturator foramen for placement of the twosoft tissue anchors.

Exemplary insertion tools having two needles may include two needlesthat extend side-by-side in parallel or along identical curves from aproximal end connected to a handle to a distal end having a tip or othersurface useful to engage a soft tissue anchor. According to theseembodiments, two needles can optionally and preferably both connect tothe handle at locations of a plane defined by a midplane of the handle.Exemplary sets of two curved needles can include the same curve (e.g.,can be co-planar, parallel, or contained by a single curved plane). Eachneedle can include a distal end (tip) that engages a soft tissue anchorin a manner that allows the needle to push the soft tissue anchorthrough a tissue path and place the soft tissue anchor at a desiredlocation of soft tissue at a region of an obturator foramen. Twoengaging surfaces (tip) supported by a single handle allow the insertiontool to engage both soft tissue anchors simultaneously to push both softtissue anchors into place in a single step.

An example of an embodiment of an insertion tool is shown at FIGS. 3A,3B, and 3C. FIG. 3A is a side view, FIG. 3B is a front, top, perspectiveview, and FIG. 3C is a top view of insertion tool 150. As illustrated,insertion tool 150 includes two needles, 152, with proximal endsconnected to an end of handle 154 and distal ends 156 including tips 158for engaging soft tissue anchors (e.g., soft tissue anchors 112 of FIGS.1 and 2). Handle 154 is of a non-circular shape to allow grasping andorientation; midplane (M at FIG. 3A) extends laterally through handle154 and includes locations at which the proximal ends of needles 152connect to handle 154. Markings 153 can be located to denote a desiredlength of insertion (of a needle) during a surgical procedure. Thedistance between needles 152 can be a distance that matches a distancebetween two soft tissue anchors located at one or more distal ends ofone or more extension portion on one side of an implant, and may be,e.g., a distance in the range of 1.2 to 1.8 centimeters.

The invention also relates to surgical assemblies or kits for treatingincontinence, including an implant and insertion tool as described andillustrated. An exemplary kit can include an implant as shown at FIG. 1or 2 and an insertion tool as shown at FIG. 3A.

1-15. (canceled)
 16. A method of treating urinary incontinence in amale, the method comprising: providing an implant comprising a centralsupport portion comprising two opposing sides and two opposing ends, andcapable of supporting a urethra, at least two extension portionsextending from opposing sides of the central support portion, eachextension portion comprising a proximal end attached to the centralsupport portion, and a distal end, four soft tissue anchors, eachlocated at a distal end of an extension portion, two on a right side ofthe implant and two on a left side of the implant, wherein when thecentral support portion is placed to support the urethra, the extensionportions are capable of extending from the central support portion tosoft tissue at a region of an obturator foramen, providing an insertiontool comprising a first needle comprising a proximal end and a distalend, the proximal end connected to the handle and the distal end adaptedto engage a soft tissue anchor, and a second needle comprising aproximal end and a distal end, the proximal end connected to the handleand the distal end adapted to engage a soft tissue anchor, creating amedial incision at a perineum, placing the central support portion tosupport a urethra, engaging the two needle tips with two soft tissueanchors on a right side of the implant and placing the soft tissueanchors through tissue paths extending toward a region of an obturatorforamen on one side of the patient, and engaging the two needle tipswith two soft tissue anchors on a left side of the implant and placingthe soft tissue anchors through tissue paths extending toward a regionof an obturator foramen on another side of the patient.
 17. A methodaccording to claim 16 comprising placing two soft tissue anchors on aright side of the implant at support tissue selected from endopelvicfascia, obturator intemus muscle, and combinations thereof, on a firstside of the patient, and placing two soft tissue anchors on a left sideof the implant at support tissue selected from endopelvic fascia,obturator intemus muscle, and combinations thereof, on a second side ofthe patient.
 18. A method according to claim 16, comprising creating anincision at the perineum, exposing bulbospongiosus muscle, dissectingbulbospongiosus muscle to expose corpus spongiosum, and placing thecentral support portion to contact the corpus spongiosum.
 19. A methodaccording to claim 16 wherein the insertion tool comprises a handle, twoneedles extending from proximal ends connected to the handle to distalends, and a tip at a distal end of each needle, the tip capable ofengaging a soft tissue anchor.
 20. A method according to claim 16,wherein the at least two extension portions comprise: a left extensionportion having a soft tissue anchor at a distal end, and a rightextension portion having a soft tissue anchor at a distal end.
 21. Amethod according to claim 20 wherein the left extension portion has awidth in the range from 2.4 to 4 centimeters and two soft tissue anchorsat the distal end, and the right extension portion has a width in therange from 2.4 to 4 centimeters and two soft tissue anchors at thedistal end.
 22. A method according to claim 16 wherein the at least twoextension portions comprising a left anterior extension portion having asoft tissue anchor at a distal end, a left posterior extension portionhaving a soft tissue anchor at a distal end, a right anterior extensionportion having a soft tissue anchor at a distal end, and a rightposterior extension portion having a soft tissue anchor at a distal end.23. A method according to claim 22 wherein each posterior extensionportion has a length that is shorter than each anterior extensionportion.
 24. A method according to claim 22 wherein each extensionportion has a width in the range from 1.2 to 1.8 centimeters.
 25. Amethod according to claim 16 wherein the implant comprising a one tissueanchor located along a length of an extension portion between theproximal end and the distal end.
 26. A method according to claim 16wherein the extension portions have a length in the range from 0.8 to1.2 inches.
 27. A method according to claim 16 wherein the first andsecond needles are of the same length and if curved exhibit the samecurvature.
 28. A method according to claim 16 wherein the handlecomprises a midplane and the first and second needles lie in themidplane.